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A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Obese Patients

NCT03106974 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2017-04-14

No results posted yet for this study

Summary

Airway management in obese patients has to consider that mask ventilation (DMV) risk is increased and difficult tracheal intubation (DTI) risk may be increased too.

In obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction and after tracheal intubation, because oxygenation maintenance is the cornerstone of the airway management of the obese patient.

Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However, sometimes this technique is ineffective and poorly tolerated by the obese patient.

The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult airway management.

However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy in obese patients.

Conditions

  • Endotracheal Intubation
  • Obesity
  • Desaturation
  • Ventilation

Interventions

DEVICE

orotracheal intubation Macintosh Laryngoscope

orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

DEVICE

orotracheal intubation Totaltrack VLM

orotracheal intubation (OTI) after induction of anesthesia and complete relaxation

Sponsors & Collaborators

  • AnestesiaR

    lead OTHER

Principal Investigators

  • Maria Luisa Mariscal Flores, M.D. · Hospital Universitario Getafe

  • Míriam Sánchez Merchante, M.D. · Hospital Universitario Fundación Alcorcón

  • Sergio D. Bergese, M.D. · Clinical Faculty - Wexner Medical Center at The Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-05-01
Completion
2019-05-01
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106974 on ClinicalTrials.gov